Toxicology Lead, West Coast Hub

Job DescriptionBiogen's West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.About This Role:The Toxicology Lead, West Coast Hub role will report to the Head of Clinical Pharmacology, WCH with matrixed reporting to the Head of Discovery Toxicology and/or the Head of Development Toxicology. The primary responsibilities of this position are to provide strategic nonclinical safety expertise and representation for clinical development programs from discovery through post-marketing, and includes the following job duties:

• Apply a broad understanding of toxicology, pharmacology, drug metabolism/pharmacokinetics (DMPK) and regulatory sciences to design all types of toxicology studies required to support clinical development, regulatory strategies and registration of biopharmaceuticals. This may include safety assessment of novel device and delivery systems.
• Apply in-depth intellectual and technical expertise in toxicology and drug development to the assigned programs.
• Develop appropriate preclinical and nonclinical safety testing strategies that are tailored to the therapeutic modality (e.g., small molecule, biologic), including design and oversight of in vitro and in vivo toxicology studies.
• Develop risk assessments to inform key decision points and progression of drug candidates through stages of development.
• Ensure that the preclinical/nonclinical safety plan for their programs is aligned with the clinical development plan and program objectives.
• Apply knowledge of applicable regulatory guidelines (ICH, FDA, GLP) to the development of testing strategies and design of appropriate toxicology studies.
• Represent Preclinical and/or Nonclinical Safety on program teams and contribute to the program team's goals and deliverables.
• Collaborate effectively with other functional groups (study management, pathology, clinical, regulatory, research, DMPK, biomarkers, clinical pharmacology, clinical safety, CMC, etc.) on program-related tasks and objectives.
• Be able to absorb and synthesize a broad range of data from toxicology, pharmacology, and PK/ADME studies to complete the nonclinical risk assessment and establish safe use conditions in humans for novel therapies.
• Prepare high quality regulatory documents for submission to support clinical development and marketing authorizations globally.
• Represent the preclinical and/or nonclinical safety function at country-specific regulatory meetings for their programs.

Qualifications

• Ph.D. in Toxicology, Pharmacology, or closely related field.
• 8-12 years of combined toxicology and drug development experience in a biopharmaceutical setting.
• Biologics/Large Molecule experience
• Toxicology board certification preferred.
• Working knowledge and experience in all phases of research and development for biopharmaceuticals.
• A high degree of familiarity with applicable regulatory guidelines (ICH, FDA, GLP, etc.); prior experience with regulatory agency interactions desired.
• Demonstrated experience and expertise with both GLP and non-GLP compliant in vitro and in vivo toxicology study design, conduct and reporting.
• Proven leadership, organizational and time management skills, including the ability to lead teams and interact effectively with internal/external experts for the conduct of toxicology studies and regulatory submissions.
• Must possess good communication and technical writing skills and be capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts.
• Demonstrated ability to mentor and develop less experienced toxicologists and nonclinical safety scientists.

Additional InformationThe base salary range for this position is $168,000 - $231,000. Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.Regular employees are eligible to receive both short term and long-termincentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees and their families' physical, financial, emotional, and social well-being; including, but not limited to:

• Medical, Dental, Vision, & Life insurances
• Fitness & Wellness programs including a fitness reimbursement
• Short- and Long-Term Disability insurance
• A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
• Up to 12 company paid holidays + 3 days off for Personal Significance
• 80 hours of sick time per calendar year
• Paid Maternity and Parental Leave benefit
• 401(k) program participation with company matched contributions
• Employee stock purchase plan
• Tuition reimbursement of up to $10,000 per calendar year
• Employee Resource Groups participation

Why Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.